Assurance Infusion Recalls Infusion Syringes Due to Sterility Concerns
Assurance Infusion is recalling specific syringes containing a combination of drugs due to a lack of sterility assurance.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the risk of infection associated with a lack of sterility assurance in an injectable product.
Plain-English summary
Assurance Infusion is recalling a specific lot of 20 mL syringes containing a combination of clonazepam, morphine, and sufentanil. The recall is being conducted because of a lack of sterility assurance for the product.
The affected product is identified by Lot 12162019@21 with an expiration date of 12/25/2019. The recall covers distribution nationwide within the United States.
Consumers and healthcare providers should stop using the affected syringes and contact Assurance Infusion at (713) 533-8800 for further instructions.
The recalled product
- Product
- CLON 750MCG/MORP 30MG/SUF 37.5MCG/ML in 20 mL syringe Assurance Infusion (713) 533-8800
- Manufacturer
- Assurance Infusion
- Category
- Drug — Injectable
- Hazard
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot: 12162019@21 Exp. 12/25/2019
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 118 recalled by Assurance Infusion under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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